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TRICCOP: Transfusion Requirements in Critically Ill Oncologic Patient

Sponsor
Instituto do Cancer do Estado de São Paulo (Other)
Overall Status
Unknown status
CT.gov ID
NCT01648946
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
12
Duration (Months)
25
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Blood transfusion in critical ill patients has been associated to several complications and worse outcome. Particularly in oncologic patients, red blood cell transfusion has been investigated as a factor of worse outcome and cancer recurrence due impairment of cellular immunity. Although red blood cell transfusion has decreased in worldwide clinical practice, this issue still remains a matter of controversy in oncologic patients. There are no prospective studies comparing outcomes between restrictive or liberal blood transfusion strategy in oncologic critical patients. This study is a prospective and randomized study comparing clinical outcomes between two strategies of transfusion in oncologic critical patients - liberal or restrictive.

Condition or Disease Intervention/Treatment Phase
  • Biological: Red blood cell transfusion
  • Biological: Red blood cell transfusion
 Phase 3

Detailed Description

Blood transfusion is commonly performed in critically ill patients, particularly in oncologic patients. However, there are many studies reporting adverse effects of this intervention and final data on benefits are not available. There are no prospective studies in oncologic patients regarding red blood cell transfusions requirements. There are observational and experimental studies suggesting worse outcomes including higher rates of infection and other clinical complications, maybe higher cancer recurrence, in patients submitted to red blood transfusion. Hemoglobin levels around 9 g/dL are usually recommended although not based in evidence . The investigators purpose is to prospectively evaluate two strategies of transfusion in 400 patients with cancer admitted to intensive care unit for severe clinical condition: a liberal strategy - patients receive blood transfusion when hemoglobin is lower than 9 g/dL since the admission to ICU until ICU discharge; a restrictive strategy - patients receive blood transfusion only when hemoglobin is lower than 7 g/dL.

Clinical outcomes, costs and quality of life will be compared.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Transfusion Requirements in Critical Clinical Oncologic Patients: a Phase 3 Randomized Controlled Clinical Trial (TRICCOP STUDY)
Study Start Date :
Jun 1, 2012
Anticipated Primary Completion Date :
Jun 1, 2013
Anticipated Study Completion Date :
Jun 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Liberal Transfusion Strategy

Red blood cell (RBC) transfusion will be given when hemoglobin falls below 9 g/dL since ICU admission until the discharge of intensive care unit. Following administration of 1 RBC unit, a repetition of hemoglobin levels is performed; if a patient's hemoglobin level is 9 g/dL or higher, no additional transfusion is necessary.

Biological: Red blood cell transfusion
Red blood cell (RBC) transfusion will be given when hemoglobin falls below 9 g/dL since ICU admission until the discharge of intensive care unit. Following administration of 1 RBC unit, a repetition of hemoglobin levels is performed; if a patient's hemoglobin level is 9 g/dL or higher, no additional transfusion is necessary.
Other Names:
  • • Red blood cells
  • • Transfusion
  • • Liberal
  • • Oncologic critically ill patient

    		•
    Active Comparator: Restrictive Transfusion Strategy

    Red blood cell (RBC) transfusion will be only given when hemoglobin falls below 7 g/dL since ICU admission until the discharge of intensive care unit. Following administration of 1 RBC unit, a repetition of the hematocrit is performed; if a patient's hemoglobin is 7 g/dL or higher, no additional transfusion is necessary.

    Biological: Red blood cell transfusion
    Red blood cell (RBC) transfusion will be only given when hemoglobin falls below 7 g/dL since ICU admission until the discharge of intensive care unit. Following administration of 1 RBC unit, a repetition of the hematocrit is performed; if a patient's hemoglobin is 7 g/dL or higher, no additional transfusion is necessary.
    Other Names:
  • • Red blood cells
  • • Transfusion
  • • Restrictive
  • • Oncologic critically ill patient

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To compare mortality between groups 28 day after ICU admission [28 days after ICU admission]

    Secondary Outcome Measures

    1. To compare length of stay in ICU between groups [90 days]

    2. To compare length of stay in hospital between groups [90 days]

    3. To compare days free of organ dysfunction between groups [28 days]

    4. Adverse effects of transfusion [Followed up until ICU discharge; an expected average of one week]

      I. Haemolytic complications after transfusion of RBC; Defined by the clinician on the basis of haemoglobinuria or increased free plasma haemoglobin. II. Anaphylactic/allergic reactions; Defined by the clinician on the basis of mucocutaneous signs and symptoms. III. Transfusion associated acute lung injury (TRALI); defined as: Acute or worsening hypoxaemia ((PaO2/FiO2 < 40 (PaO2 in kPa) or <300 (PaO2 in mmHg) regardless of PEEP) OR > 50% relative increase in FiO2. Occurrence within 6 hours after RBC transfusion AND Acute or worsening pulmonary infiltrates on frontal chest x-ray OR clinical signs of overt pulmonary oedema. IV. Ischaemic events; Defined as either myocardial, cerebral, intestinal or acute limb ischaemia

    5. Mortality [60 day]

      All cause 60 day mortality

    6. All cause 90 day mortality All cause 90 day mortality Mortality [90 day]

      All cause 90 day mortality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adults patients with cancer admitted to ICU due to severe clinical condition AND

    • Septic shock diagnosis AND

    • Solid neoplasm AND

    • Written informed consent

    Exclusion Criteria:

    • Age less than 18 years OR

    • Leukemia or myelodysplastic syndrome OR

    • Hematologic neoplasm OR

    • Palliative treatment OR

    • Renal Chronic Failure in Renal Replacement Therapy OR

    • Karnofsky Status < 50 OR

    • Previous thrombocytopenia (platelet number lower than 50.000/mm3) OR

    • Previous known coagulopathy OR

    • Life-threatening bleeding OR

    • Documented wish against transfusion OR

    • Patients who refused participation in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Instituto do Cancer do Estado de Sao Paulo - Faculdade de Medicina da Universidade de Sao Paulo Sao Paulo Brazil 01246-000

    Sponsors and Collaborators

    • Instituto do Cancer do Estado de São Paulo

    Investigators

    • Study Director: Paulo G. Hoff, MD, PhD, ICESP - HCFMUSP

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fabricio Sanchez Bergamin, Principal Investigator, Instituto do Cancer do Estado de São Paulo
    ClinicalTrials.gov Identifier:
    NCT01648946
    Other Study ID Numbers:
    • FSB
    First Posted:
    Jul 25, 2012
    Last Update Posted:
    Nov 6, 2012
    Last Verified:
    Nov 1, 2012
    Keywords provided by Fabricio Sanchez Bergamin, Principal Investigator, Instituto do Cancer do Estado de São Paulo
    Strategies of transfusion
    Red blood cells
    Liberal
    Restrictive
    Oncologic critically ill patients

    Study Results

    No Results Posted as of Nov 6, 2012